BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP

    MDR report key: 15870163 · Received November 28, 2022

    Report

    Report Number
    1416980-2022-06474
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    October 31, 2022
    Report Date
    December 27, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SET, I.V. FLUID TRANSFER : AVE. SEVERIANO CUEVAS # 18 CARR # 2 KM 141.1 BO. C SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H4: THE LOT WAS MANUFACTURED FROM MAY 09, 2022 - MAY 10, 2022. H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED WHICH OBSERVED A SMALL TEAR AT THE LOWER RIGHT SIDE EDGE AREA OF THE BAG. FUNCTIONAL TESTING WAS PERFORMED WHICH REVEALED A LEAK IN THE AFFECTED AREA. MAGNIFIED INSPECTION VERIFIED A TEAR/HOLE WHERE THE LEAK OCCURRED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 3000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM AN UNSPECIFIED LOCATION. THIS ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743029 EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA 60367391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown